hydromorphone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
opioid receptor antagonists/agonists, morphinan derivates	1393	466-99-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: hydromorphone dihydromorphinone dihydromorphone dimorphone hydromorphon hydromorphone hydrochloride hydromorphone HCl	An opioid analgesic made from MORPHINE and used mainly as an analgesic. It has a shorter duration of action than morphine. Molecular weight: 285.34 Formula: C17H19NO3 CLOGP: 0.72 LIPINSKI: 0 HAC: 4 HDO: 1 TPSA: 49.77 ALOGS: -1.81 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

hydromorphone
dihydromorphinone
dihydromorphone
dimorphone
hydromorphon
hydromorphone hydrochloride
hydromorphone HCl

An opioid analgesic made from MORPHINE and used mainly as an analgesic. It has a shorter duration of action than morphine.

Molecular weight: 285.34
Formula: C17H19NO3
CLOGP: 0.72
LIPINSKI: 0
HAC: 4
HDO: 1
TPSA: 49.77
ALOGS: -1.81
ROTB: 0

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
20	mg	O
4	mg	P
4	mg	R

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	6 %	Benet LZ, Broccatelli F, Oprea TI
BA (Bioavailability)	42 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	4.30 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	28 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	2.30 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	10 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	1.20 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.86 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Jan. 11, 1984	FDA	PURDUE PHARM PRODS

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug hypersensitivity	512.20	10.14	1466	112500	309221	63065835
Temperature regulation disorder	303.71	10.14	169	113797	5963	63369093
Macular degeneration	270.81	10.14	273	113693	24103	63350953
Food allergy	216.85	10.14	173	113793	11228	63363828
Coeliac disease	191.33	10.14	169	113797	12628	63362428
Constipation	173.36	10.14	831	113135	224112	63150944
Immunodeficiency	159	10.14	189	113777	20065	63354991
Pneumonia viral	152.35	10.14	121	113845	7801	63367255
Drug withdrawal syndrome	148.27	10.14	212	113754	26982	63348074
Alopecia	141.46	10.14	243	113723	337293	63037763

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug dependence	243.23	11.34	247	57440	23970	34875274
Appendicolith	218.03	11.34	150	57537	8451	34890793
Nausea	165.02	11.34	1040	56647	338868	34560376
Sedation	163.03	11.34	187	57500	20819	34878425
Appendicitis	161.51	11.34	158	57529	14649	34884595
Stress	145.67	11.34	213	57474	30134	34869110
Hyperaesthesia	144.63	11.34	92	57595	4538	34894706
Drug withdrawal syndrome	136.42	11.34	166	57521	19668	34879576
Constipation	135.00	11.34	514	57173	136468	34762776
Pain	124.88	11.34	666	57021	204009	34695235

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug hypersensitivity	371.26	10.06	1290	143551	297626	79301921
Temperature regulation disorder	292.70	10.06	163	144678	5690	79593857
Constipation	276.93	10.06	1132	143709	281918	79317629
Drug withdrawal syndrome	239.02	10.06	305	144536	34413	79565134
Nausea	214.91	10.06	2665	142176	954531	78645016
Food allergy	212.16	10.06	168	144673	10656	79588891
Hyperaesthesia	210.68	10.06	176	144665	12046	79587501
Appendicolith	203.50	10.06	149	144692	8402	79591145
Coeliac disease	196.78	10.06	164	144677	11187	79588360
Drug dependence	191.15	10.06	298	144543	40471	79559076

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N02AA03	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
ATC	N02AA53	NERVOUS SYSTEM ANALGESICS OPIOIDS Natural opium alkaloids
ATC	N02AG04	NERVOUS SYSTEM ANALGESICS OPIOIDS Opioids in combination with antispasmodics
CHEBI has role	CHEBI:35482	narcotic analgesic
CHEBI has role	CHEBI:55322	mu-opioid agonists
FDA EPC	N0000175690	Opioid Agonist
FDA MoA	N0000175684	Full Opioid Agonists
MeSH PA	D000700	Analgesics
MeSH PA	D000701	Analgesics, Opioid
MeSH PA	D002491	Central Nervous System Agents

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Pain	indication	22253000
Cough	indication	49727002
Severe pain	indication	76948002
Common cold	indication	82272006	DOID:10459
Acute postoperative pain	indication	107401000119105
Severe Pain with Opioid Tolerance	indication
Chronic Pain with Opioid Tolerance	indication
Suicidal thoughts	contraindication	6471006
Dependent drug abuse	contraindication	6525002
Alcohol withdrawal delirium	contraindication	8635005

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.67	acidic
pKa2	8.64	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Mu-type opioid receptor	GPCR	P35372	OPRM_HUMAN	AGONIST	Ki	9.55	CHEMBL	CHEMBL
Kappa-type opioid receptor	GPCR	P41145	OPRK_HUMAN		Ki	8.55	CHEMBL
Delta-type opioid receptor	GPCR	P41143	OPRD_HUMAN		Ki	7.42	CHEMBL
Opioid receptor	GPCR		OPRD_RAT OPRM_RAT OPRK_RAT SGMR1_RAT		EC50	9	CHEMBL

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External reference:

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ID	Source
001547	NDDF
004622	NDDF
1470	MMSL
1770	INN_ID
203177	RXNORM
387485001	SNOMEDCT_US
4018035	VANDF
4019779	VUID
4019779	VANDF
414428000	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Hydromorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0264	TABLET	4 mg	ORAL	ANDA	33 sections
Hydromorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0264	TABLET	4 mg	ORAL	ANDA	33 sections
Hydromorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0264	TABLET	4 mg	ORAL	ANDA	33 sections
Hydromorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0265	TABLET	8 mg	ORAL	ANDA	33 sections
Hydromorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0265	TABLET	8 mg	ORAL	ANDA	33 sections
Hydromorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0265	TABLET	8 mg	ORAL	ANDA	33 sections
Hydromorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0386	SOLUTION	1 mg	ORAL	ANDA	33 sections
Hydromorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0386	SOLUTION	1 mg	ORAL	ANDA	33 sections
Hydromorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0386	SOLUTION	1 mg	ORAL	ANDA	33 sections
Hydromorphone Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0406-3243	TABLET	2 mg	ORAL	ANDA	38 sections

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